David Rosen

David Rosen

Foley & Lardner LLP

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Recent Amendments to New York’s Not-For-Profit Corporations Law

Time to Update Your Corporate Bylaws? New York Gov. Andrew Cuomo signed the New York Non-Profit Revitalization Act of 2013 (Act), into law in December 2013, thereby adopting important changes to the governance of...more

3/14/2014 - Choice of Entity Corporate Governance Non-Profits

FDA Takes Steps to Declare Partially Hydrogenated Oils No Longer GRAS and Seeks Comments

On November 7, 2013, the Food and Drug Administration (FDA) announced that it has tentatively determined that partially hydrogenated oils (PHOs) are no longer generally recognized as safe (GRAS) for any use in food. PHOs are...more

11/8/2013 - FDA Food Safety Trans Fat

FDA Submits Final Guidance on Mobile Medical Apps

Last week, The U.S. Food and Drug Administration (the “FDA”) issued long-awaited final guidance for the mobile medical applications (“Apps”) industry and FDA staff (the “Guidance”). The Guidance notes that it contains...more

10/4/2013 - FDA FDCA Medical Devices Mobile Apps

Supreme Court Game-Changer: Rule of Reason Applies to ANDA Reverse Payment Settlements

In Federal Trade Commission v. Actavis, Inc., No. 12-416, 2013 U.S. LEXIS 4545 (U.S. June 17, 2013), the U.S. Supreme Court reversed the Eleventh Circuit decision in FTC v. Watson Pharmaceuticals, Inc., 677 F.3d 1298 (2012),...more

6/19/2013 - Actavis Inc. ANDA FTC FTC v Actavis Generic Drugs Patents Pay-For-Delay Pharmaceutical Prescription Drugs Reverse Payment Settlement Agreements SCOTUS

Medical Device Industry Responds to FDA's Overseas Clinical Trial Proposed Rule

In a resounding manner, members of the medical device industry recently filed comments reacting to the Food and Drug Administration’s proposed rule to strengthen its oversight of overseas clinical studies of medical devices....more

6/17/2013 - Clinical Trials FDA Medical Devices

FDA's Plan to Regulate LDTs

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

6/17/2013 - DNA Enforcement FDA Laboratory Developed Tests Regulation

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